Regulatory Pathways for Clearance or Approval of IVDs
May 2010
Jeff Gibbs has authored a chapter in FDLI's In Vitro Diagnostics: The Complete Regulatory Guide book. His chapter focuses on IVDs that are developed and submitted to FDA for commercialization and addresses some of the key aspects of marketing IVDs, including the regulatory review processes, intended use, data requirements and the Quality System Regulation (QSR).
Click here to view the chapter
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